Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing

Not Applicable

Completed

Conditions: SARS-CoV2 Infection

Interventions: Device: Testing for SARS CoV2 Antigen and Antibody

Registration Number: NCT05607147

Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary: 10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated DHCWs' perceptions of safety and adoption of risk mitigation behavior. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. Samples were processed using an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the Spike protein. Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study.

Detailed Description: 10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the DHCW arm of the study. The DCHWs underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (See DHCW Arm in Results Section). Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study (BD Veritor Plus Analyzer, BD Sciences). The DHCWs' perceptions of safety and adoption of risk mitigation behavior were interrogated. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a Neoteryx Mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). Briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. Following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. Each microsampler tip (20µl in the present study) was added to 200 μl VAMS extraction buffer (1x PBS (Corning) supplemented with 1% bovine serum albumin (Roche Diagnostics, Mannheim, Germany) and 0.5% Tween20 (Sigma, MO, USA) in a 1 ml deep-well 96 well plate (Greiner bio-one-780261). The plate was then covered with an adhesive seal and incubated 16 hours at 40C on a shaker at 250 rpm. The resulting eluates were heat inactivated at 560C for 60 minutes and centrifugation to collect the supernatant (eluate). Eluates were further processed for an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine

Exclusion Criteria

Previous participation

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 testing	Testing for SARS CoV2 Antigen and Antibody	There is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral Antigen and antibody to the virus as described.

Primary Outcome Measures

Name	Time	Method
Dental Health Care Worker (DHCW) Willingness to Participate in the Study	Day 1	Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study
Number of DHCW With Complete Surveys	Through study completion (3 months)	Number of participants with complete Start-of-study, Triage and End-of-Study surveys
DHCW Test Completion	Day 28	Percentage of DHCWs with completed SARS-CoV-2 test completed
DHCW Ease of Complying With Protocol	Day 28	Number of DHCWs who reported ease of complying with protocol as their choices on questions on the survey enquiring ease at start-of-study, end-of-study
DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing	Day 28	Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing

Secondary Outcome Measures

Name	Time	Method
SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive	28 days	Number of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing
Positive Antibody Testing	28 days	Number of participants who tested positive for antibody to SARS-CoV2
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work	28 days	Percentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study